NCT00663637

Brief Summary

The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (Complete Airway Management Catheters: CAM Rescue Cath and CAM Endotrach Cath).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

May 29, 2008

Status Verified

April 1, 2008

First QC Date

April 18, 2008

Last Update Submit

May 28, 2008

Conditions

Mechanical VentilationPneumonia

Keywords

endotracheal tube obstruction, occlusionmechanical ventilation, complicationwork of breathingairway resistancesecretionspneumonia, ventilator associatedbiofilmsendotracheal tube

Outcome Measures

Primary Outcomes (1)

  • work of breathing

    pre-extubation

Secondary Outcomes (1)

  • endotracheal tube patency

    pre-extubation

Interventions

CAM (Complete Airway Management) CathetersDEVICE

Prior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath.

Also known as: CAM Rescue Cath, CAM Endotrach Cath

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving medical care in adult intensive care unit setting
  • Patients who have been intubated and mechanically ventilated for at least 12 hours
  • Patients intubated with an endotracheal tube with an internal diameter of 7.0 mm or greater

You may not qualify if:

  • Patients receiving medical care in a setting not compatible with an adult intensive care unit
  • Patients who have been intubated and mechanically ventilated for less than 12 hours
  • Patients intubated with an endotracheal tube with an internal diameter of 6.5 mm or less
  • Patients intubated with dual lumen or steel-reinforced endotracheal tubes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

MeSH Terms

Conditions

PneumoniaBites and StingsPneumonia, Ventilator-Associated

Interventions

Complementary TherapiesCatheters

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPoisoningChemically-Induced DisordersWounds and InjuriesHealthcare-Associated PneumoniaCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsEquipment and Supplies

Study Officials

  • Orlando V. Morejon, MD

    Saint Francis Medical Center; Omneotech

    STUDY DIRECTOR

Central Study Contacts

Robert H. Stone, RRT

CONTACT

573-331-3000bstone@sfmc.net

Stephen S. Bricknell, RRT

CONTACT

573-331-3000sbricknell@sfmc.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

April 1, 2008

Last Updated

May 29, 2008

Record last verified: 2008-04

Locations

US(1)